This graphic tracks regulatory approvals for injectable cabotegravir and lenacapavir for PrEP as of October 2026. For additional details on product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Injectable PrEP Regulatory Approvals
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of October 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Source of Lenacapavir for PrEP Supply in Africa
Lenacapavir for PrEP has now reached seventeen countries in Africa. This map offers more detail on the LEN rollout as of October 2026.
Long-Acting PrEP Generic Manufacturers
Licenses have been granted to manufacturers across multiple low- and middle-income countries to produce generic long-acting PrEP products. Cabotegravir (CAB) and Lenacapavir (LEN) are approved and rolling out, while alimatravir (AMI) is in Phase 3 efficacy trials. Generic manufacturing can play an important role in expanding access to PrEP, and licensing to three African manufacturers for AMI is a notable step toward strengthening regional supply and affordability.
EXPrESSIVE Phase III Program Countries of Alimatravir
Seventeen countries are hosting sites for the Phase III efficacy trials of a monthly PrEP pill, called MK-8527, now known as alimatravir, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase III trials at IAS 2025 in Kigali. Alimatravir (AMI) was found to be safe and well-tolerated in Phase II clinical trials.
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with injectable lenacapavir for PrEP over three years. Supply of LEN began arriving in countries in late 2025 with service delivery starting in early 2026.
HIV Prevention Pipeline: Products to Watch
From the People’s Research Agenda, this graphic tracks the pipeline of potential new HIV prevention options across broadly neutralizing antibodies, preventive vaccines, pre-exposure prophylaxis, and multipurpose technologies.
ARV-Based and Multipurpose Prevention Technology R&D Pipeline
The pipeline of non-vaccine HIV prevention products includes oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals and more. Also pictured are the range of MPTs in development that aim to reduce the risk of HIV and STIs and/or provide effective contraception for women.
At A Glance: The MPT R&D Pipeline
This graphic shows the status of products in development.
ISL/LEN Phase 3 Development Program
At AIDS 2026, Merck and Gilead presented detailed results from the Phase 3 ISLEND trials, showing that an investigational weekly oral single-tablet treatment regimen combining islatravir (ISL) from Merck/MSD and lenacapavir (LEN) from Gilead sustained viral suppression as effectively as daily oral antiretroviral therapy (ART) at week 48; the studies will continue to week 96. This infographic features data from Gilead’s AIDS 2026 presentations on ISLEND-1 and ISLEND-2 trials.